Manager for Submissions team
Category:
Manufacturing
Location:
Søborg, Capital Region of Denmark, DK
Are you an experienced leader with strong people skills and a genuine interest in business strategy? If so, this position might be for you! We are offering a Manager position for the newly formed New Product Introduction (NPI) Submissions team at Novo Nordisk. As leader of this team, your responsibility will be to secure the delivery of the Drug Product Manufacturing sections of regulatory submissions across Novo Nordisk’s injectables portfolio, including Rare Diseases, Diabetes, and Obesity products. If this sounds interesting and you are ready for the challenge, you could be our new Manager for the NPI Submissions team in Aseptic Manufacturing Science & Technology (AMSAT).
The Position
As Manager of the NPI Submissions team, you will lead 10–15 dedicated regulatory writers. The team’s primary task is to prepare the Drug Product sections of regulatory submissions (NDAs, BLAs, renewals, variations) and handle the Q&As that follow, ensuring the successful approval of Novo Nordisk’s injectable products worldwide. The work critically depends on strong cross-organizational collaboration with subject matter experts from sister areas in AMSAT and the Regulatory Affairs team. Through this work, the team significantly influences the success of product launches and lifecycle management within Novo Nordisk’s portfolio.
Your key responsibilities are:
- Drive innovation and efficiency within the team by ensuring clear prioritization, executing strategies, and meeting deadlines.
- Lead the team by fostering employee engagement, defining individual business and behavior goals, overseeing hiring and training, championing personal and professional growth, and tracking progress on project tasks.
- Allocate and manage resources to support key projects.
- Collaborate with stakeholders across a broad internal and external landscape to ensure smooth workflow, seamless writing and reviewing processes, and success across the organization.
The work of the team is both high-paced and highly rewarding. The team’s success and ability to deliver have a direct impact on company business performance. Your ability to engage, motivate, and inspire the team will translate into tangible results for Novo Nordisk
As a leader, you are open, honest, and curious. You take joy in empowering your team to shine and succeed through collaboration and teamwork. You are structured, set clear goals, and communicate them effectively, ensuring everyone understands priorities and objectives. You thrive in complex environments and have a keen interest in strategy, complemented by a holistic mindset for navigating organizational boundaries.
Qualifications
To succeed in this role, you should have:
- An academic background in Life Sciences, Engineering, Pharmacy, or a similar field.
- A minimum of 3 years of leadership experience in product development or pharmaceutical production. Experience in aseptic manufacturing processes and regulatory submissions is advantageous.
- Experience in change management is a definite plus.
- The ability to balance short-term deliverables with long-term focus, prioritizing tasks and fostering transparency within your team.
- Effective communication and collaboration skills.
- Fluency in English.
You enjoy working with people, have excellent interpersonal skills, and actively seek ways to improve and develop your leadership abilities. You inspire and energize those around you, set clear and ambitious goals, and lead with empathy and by example.
You understand the importance of building strong relationships and earning trust and respect from colleagues and employees. You excel at bridging cultural, professional, and geographical distances, focusing on delivering sustainable solutions in a dynamic, ever-changing environment.
We encourage you to apply even if you don’t meet all the listed qualifications but possess relevant skills and experience.
About the Department
In Aseptic Manufacturing (AM), we produce high-quality injectable products for diabetes, bleeding disorders, growth hormone treatments, and obesity. The AMSAT organization is a global function supporting all manufacturing sites worldwide with expertise in process, product, and analytics.
The New Product Introduction (NPI) area consists of 90 employees currently located in Søborg. The main responsibility of this department is transitioning development-stage drug products into large-scale production. This includes production design, material and process sciences, product stability (including specification setting and trending), coordination of manufacturing for late-phase clinical trials, and regulatory filing for market approval.
The Submissions team, part of the Submissions and Reference Materials department in NPI, was formed at the start of 2025. The team provides regulatory writing support across three AMSAT areas: Product Lifecycle Management, Manufacturing Science and Transfers, and NPI. The team comprises regulatory professionals and submission specialists, each playing a critical role in securing approval for new drug products and facilitating market launches.
Working at Novo Nordisk
At Novo Nordisk, we drive change rather than wait for it. We are a dynamic company in an equally dynamic industry, and we understand that staying ahead requires constant experimentation and excellence.
We seize opportunities for growth and development at every level of the organization. From research and development to manufacturing, marketing, and sales, our efforts are focused on advancing patient care.
Contact
For further information, feel free to contact the hiring manager: Maria Berggård Silow at +45 34 48 50 56.
Deadline
Please apply before June 22.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from including photos in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.